Register online today at https://hub.pointbiopharma.com/controlarm
August 8, 2022 – INDIANAPOLIS, INDIANA – POINT Biopharma Global Inc. (NASDAQ: PNT) (the “Company” or “POINT”), a company accelerating the discovery, development and global access to life-changing radiopharmaceuticals, announced that next week, on Thursday, August 18, 2022 at 12:00 PM ET, the Company will be presenting a 45-minute educational webinar entitled “Understanding the PNT2002 Phase 3 SPLASH Trial Control Arm”.
Topics to be presented at the webinar include:
• Overview of SPLASH trial design (including lead-in phase) and rationale for hormone switches
• What is a control arm benchmark, why PROfound1 & IMbassador2502 were selected as SPLASH benchmarks
• Review current treatment patterns, including sequencing considerations, in real-world clinical settings for mCRPC patients
The webinar will feature presentations from two Thought Leaders: Dr. Oliver Sartor & Dr. Kim Chi. They will be joined by members of the Company’s executive leadership team including Dr. Neil Fleshner, Chief Medical Officer, and Dr. Sherin Al-Safadi, VP Medical Affairs.
About Dr. Oliver Sartor
Dr. Oliver Sartor is an internationally recognized expert in prostate cancer. His medical practice and research have focused on prostate cancer since 1990 when he finished a medical oncology fellowship at the National Cancer Institute (NCI). He has published over 400 peer-reviewed articles, led or co-led multiple national and international clinical studies, including three radiopharmaceutical phase III studies pivotal for FDA approval in prostate cancer. He has lectured widely, and at last count has given invited lectures in 33 countries. He is currently the Associate Dean for Oncology, Medical Director of the Tulane Cancer Center, and serves as the Laborde Professor for Cancer Research at Tulane Medical School with appointments in both the Medicine and Urology Departments. He is the Medical Oncology Chair of the GU committee of NRG, a national cancer research group. He is also a past member of the National Cancer Institute Board of Scientific Counselors (Clinical Sciences and Epidemiology).
About Dr. Kim Chi
Dr. Kim Chi, MD is the Vice President and Chief Medical Officer of BC Cancer. His research is focused in the area of genitourinary cancers with a special interest in prostate cancer and investigational new drugs. This includes phase I, II and III clinical trials, therapeutic use of antisense oligonucleotides and mechanisms of treatment resistance. Nationally and internationally he has led a number of multi-center Phase I, II and III clinical trials, and has also contributed to clinical trials that established new standard of care for patients with advanced prostate cancer (docetaxel, abiraterone acetate, enzalutamide).
1. De Bono et al. N Engl J Med 2020; 382:2091-2102
2. Powles T, et al. Nature Med 2022; 28:144-153
About POINT Biopharma Global Inc.
POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT is transforming precision medicine by combining a portfolio of best-in-class radio-pharmaceutical assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for rare medical isotopes like actinium-225 and lutetium-177. Learn more about POINT Biopharma Global Inc. at https://www.pointbiopharma.com/. Information about POINT Biopharma Global Inc.’s Phase 3 SPLASH trial for metastatic castrate resistant prostate cancer (mCRPC) patients can be found at https://www.splashtrial.com/.
About the SPLASH Trial
The Phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in patients with PSMA-expressing mCRPC who have progressed on Androgen receptor-axis-targeted therapies (ARAT) therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study is expected to enroll approximately 400 patients across North America, Europe and the United Kingdom. Patients will be randomized 2:1 with patients in arm A receiving PNT2002 and patients in arm B receiving either Abiraterone or Enzalutamide. Patients in arm B who experience centrally assessed radiographic progression and meet protocol eligibility will have the option to crossover and receive PNT2002. Patients will be subject to follow-up for up to 5 years from first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival (rPFS). Key secondary endpoints include overall response rate (ORR), overall survival (OS), and pharmacokinetics (PK).
Additional information on the Phase 3 SPLASH trial can be found at https://www.splashtrial.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding the benefits of the recently completed business combination, as well as statements about the potential attributes and benefits of POINT’s product candidates and the format and timing of POINT’s product development activities and clinical trials. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, the outcome of any legal proceedings that may be instituted against POINT following the closing of the business combination, the risk that the business combination disrupts current plans and operations, the ability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of POINT to grow and manage growth profitably and retain its key employees, the impact of COVID-19 on POINT’s business, the ability to maintain the listing of POINT’s common stock on the NASDAQ, changes in applicable laws or regulations, the possibility that POINT may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described in POINT's S-1 registration statement filed with the SEC on July 30, 2021. Most of these factors are outside of POINT’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Investor Relations Contact:
Associate Director, Corporate Strategy